Recruiting

General Anesthesia & IV Medications

Sponsor:

University of Pennsylvania

Code:

NCT07334418

Conditions

Cesarean Section

Delivery; Trauma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

General anesthetic

Intravenous anesthetic

Study Details

Brief summary:

Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after pregnancy. Currently, the two main options for treating this pain are general anesthesia (full medically induced unconsciousness) and using intravenous medications to reduce the pain and decrease anxiety. The EAGLET-CS Pilot is a pilot randomized trial that will test the feasibility of comparing the impact of these two options for preventing PTSD in a rigorous way for those patients who experience pain during their cesarean section after the baby is out.

Conditions

Cesarean Section

Delivery; Trauma

Study ID

NCT07334418

Start date

Apr 6, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women aged 18 or older undergoing non-emergent cesarean delivery with primary neuraxial (epidural, spinal, or CSE) anesthesia. Eligible patients will be those who report severe pain during surgery, defined as pain that does not resolve with 2 trials of first-line pharmacologic therapies (e.g., epidural supplementation with local anesthetics; intravenous opioid analgesics).

Exclusion Criteria:

  • We will exclude patients who require induction of general anesthesia prior to umbilical cord clamping and by clinician determination.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: General anesthesia

Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement.

active comparator: Intravenous sedation

Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists.

Interventions

General anesthetic

standard of care general anesthesia

Intravenous anesthetic

standard of care intravenous anesthesia

Primary outcome measure

  • Consent [ Time Frame: From hospital admission through day of delivery ]

Central Contacts and Locations

Central contacts

Mark Neuman, MD

215-746-7468eagletadmin@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mark Neuman

2156624000mark.neuman@uphs.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Cesarean Section
  • Delivery; Trauma
  • C-section
  • PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-06-11.